KR890014095A - Release-controlled pharmaceuticals and preparation method thereof - Google Patents

Release-controlled pharmaceuticals and preparation method thereof Download PDF

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Publication number
KR890014095A
KR890014095A KR1019890004085A KR890004085A KR890014095A KR 890014095 A KR890014095 A KR 890014095A KR 1019890004085 A KR1019890004085 A KR 1019890004085A KR 890004085 A KR890004085 A KR 890004085A KR 890014095 A KR890014095 A KR 890014095A
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South Korea
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formulation
group
hydrophobic
polymer material
cellulose
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KR1019890004085A
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Korean (ko)
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KR950007202B1 (en
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마사요시 사메지마
가즈오 노다
요시유끼 히라가와
히로유끼 요시노
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아다찌 게이지로
다나베 세이야꾸 가부시끼가이샤
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Disclosed is a controlled release pharmaceutical preparation, comprising a core containing a pharmaceutically active ingredient, and a porous film of a hydrophobic polymeric substance or a hydrophobic polymeric substance and a hydrophilic polymeric substance, the core being coated with the porous film. Also disclosed is a method for producing the same.

Description

방출 제어형 약제 및 그의 제조방법Release-controlled pharmaceuticals and preparation method thereof

본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음Since this is an open matter, no full text was included.

Claims (14)

제약적 유효성분을 함유한 코어 물질 및 소수성 고분자 또는 소수성 중합체 물질과 친수성 중합체 물질의 다공성 피막으로 되고, 상기 코어가 상기 다공성 피막으로 피복된 방출 제어형 제제.A controlled release formulation comprising a core material containing a pharmaceutically active ingredient and a porous film of a hydrophobic polymer or a hydrophobic polymer material and a hydrophilic polymer material, wherein the core is coated with the porous film. 제1항에 있어서, 상기 다공성 피막이 약 0.4 내지 0.9의 다공도를 갖는 제제.The formulation of claim 1, wherein the porous coating has a porosity of about 0.4 to 0.9. 제2항에 있어서, 상기 다공성 피막이 약 0.5 내지 0.85의 다공도를 갖는 제제.The formulation of claim 2, wherein the porous coating has a porosity of about 0.5 to 0.85. 제1항에 있어서, 상기 다공성 피막이 소수성 중합체 물질로 된 제제.The formulation of claim 1 wherein said porous coating is of hydrophobic polymeric material. 제1항에 있어서, 상기 다공성 피막이 소수성 중합체 물질 및 친수성 중합체 물질로 된 제제.The formulation of claim 1 wherein said porous coating is of hydrophobic polymeric material and hydrophilic polymeric material. 제5항에 있어서, 상기 다공성 피막이 소수성 중합체 물질의 1중량부에 대해서 친수성 고분자 물질 0.05 내지 0.5중량부로 되는 제제.The formulation according to claim 5, wherein the porous coating is 0.05 to 0.5 parts by weight of the hydrophilic polymer material with respect to 1 part by weight of the hydrophobic polymer material. 제5항에 있어서, 상기 소수성 중합체 물질이 적어도 셀룰로오스 에테르, 셀룰로오스 에스테르, 폴리비닐 에스테르 및 4차 암모늄 알킬기를 가진 아크릴산으로 되는 군중에서 선택된 것인 제제.6. The formulation of claim 5 wherein said hydrophobic polymeric material is selected from the group consisting of at least cellulose ethers, cellulose esters, polyvinyl esters and acrylic acid with quaternary ammonium alkyl groups. 제6항에 있어서, 상기 소수성 물질이 적어도 셀룰로오스 에테르, 셀룰로오스 에스테르, 폴리비닐 에스테르 및 4차 암모늄 알킬기를 가진 아크릴형 중합체로 되는 군중에서 선택되고, 소수성 물질이 수용성 중합체 물질, 장 용해성 중합체 물질, 위 용해성 중합체 및 장 용해성 중합체 물질과 위 용해성 중합체 물질로 되는 군중에서 선택한 것인 제제.7. The method of claim 6 wherein the hydrophobic material is selected from the group consisting of acrylic polymers having at least cellulose ethers, cellulose esters, polyvinyl esters and quaternary ammonium alkyl groups, wherein the hydrophobic material is a water soluble polymer material, an enteric soluble polymer material, A formulation selected from the group consisting of soluble polymers and enteric soluble polymeric materials and gastric soluble polymeric materials. 제8항에 있어서, 수용성 중합체 물질이 임의로 황산기를 갖는 다당류, 히드록시알킬기를 갖는 다당류,카르복시알킬기를 갖는 다당류, 메틸 셀룰로오스 폴리비닐 피롤리딘, 폴리비닐 알콜 및 폴리에틸렌 글리콜로 되는 군중에서 선택된 적어도 하나이고, 장 용해성 중합체 물질이 카르복시알킬 셀룰로오스, 이염기산의 모노에스테르 결합을 갖는 셀룰로오스 유도체, 말레산 -비닐 공중합체 및 아크릴산 형 중합체로 되는 군중에서 선택된 적어도 하나이고, 위 용해성 중합체 물질이 일 - 또는 이 - 치환 아미노기를 갖는 셀룰로오스 유도체 및 일치환 아미노기를 갖는 아크릴산 중합체로 되는 군중에서 선택된 적어도 하나이고, 장 용해성 및 위용해성 중합체 물질이 비닐 피리딘 - 아크릴산형 공중합체, 일 - 또는 이 - 치환 아미노기를 가지는 카르복시메틸 다당류 및 폴리비닐 아미노산형 유도체로 되는 군중에서 선택된 적어도 하나인 제제.The method of claim 8, wherein the water-soluble polymer material is at least one selected from the group consisting of polysaccharides having a sulfate group, polysaccharides having a hydroxyalkyl group, polysaccharides having a carboxyalkyl group, methyl cellulose polyvinyl pyrrolidine, polyvinyl alcohol and polyethylene glycol Wherein the enteric polymer material is at least one selected from the group consisting of carboxyalkyl cellulose, cellulose derivatives having monoester linkages of dibasic acids, maleic acid-vinyl copolymers and acrylic acid type polymers, At least one selected from the group consisting of a cellulose derivative having a substituted amino group and an acrylic acid polymer having a monocyclic amino group, wherein the enteric and gasosoluble polymer material has a vinyl pyridine-acrylic acid copolymer, a carboxy having a mono- or di-substituted amino group. methyl At least one agent selected from the group consisting of polysaccharides and polyvinyl amino acid derivatives. 제9항에 있어서, 상기 다공성 피막이 소수성 중합체 물질 및 수용성 중합체 물질 또는 소수성 중합체 물질 및 장내성 중합체 물질로 되는 제제.10. The formulation of claim 9, wherein said porous coating is of a hydrophobic polymeric material and a water soluble polymeric material or of a hydrophobic polymeric material and an enteric resistant polymeric material. 제10항에 있어서, 상기 다공성 피막이 에틸 셀룰로오스 및 히드록시프로필 셀룰로오스인 제제.The formulation of claim 10, wherein said porous coating is ethyl cellulose and hydroxypropyl cellulose. 제11항에 있어서, 상기 다공성 피막이 에틸 셀룰로오스 및 히드록시프로필 셀룰로오스로 구성되고, 유기산이 코어내에서 제약 유효 성분과 함께 함유된 것인 제제.The formulation according to claim 11, wherein the porous coating is composed of ethyl cellulose and hydroxypropyl cellulose, and an organic acid is contained in the core together with a pharmaceutically active ingredient. 제12항에 있어서, 상기 유기산이 숙신산인 제제.13. The formulation of claim 12, wherein said organic acid is succinic acid. 제약 유효 성분을 함유한 코어 물질을 소수성 중합체 물질 또는 소수성 중합체 물질과 친수성 중합체 물질을 함유하는 물 - 유기 용매 혼합물로 분무 코팅시켜서 코어물질의 표면에 상기 중합체 물질(들)로 된 다공성 피막을 형성시키는 것으로 되는 방출 제어형 제제를 제조하는 방법.The core material containing the pharmaceutical active ingredient is spray coated with a hydrophobic polymer material or a water-organic solvent mixture containing a hydrophobic polymer material and a hydrophilic polymer material to form a porous film of the polymer material (s) on the surface of the core material. A process for the preparation of controlled release formulations. ※ 참고사항:최초출원 내용에 의하여 공개하는 것임.※ Note: The disclosure is based on the initial application.
KR1019890004085A 1988-03-31 1989-03-30 Controlled release pharmacontical preparation KR950007202B1 (en)

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JP8060488 1988-03-31
JP80604/1988 1988-03-31

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KR950007202B1 KR950007202B1 (en) 1995-07-04

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KR (1) KR950007202B1 (en)
AT (1) ATE91888T1 (en)
AU (1) AU610711B2 (en)
BG (1) BG50712A3 (en)
CA (1) CA1339078C (en)
DE (1) DE68907762T3 (en)
DK (1) DK156289A (en)
ES (1) ES2059729T5 (en)
FI (1) FI101344B (en)
FR (1) FR2629344B1 (en)
HK (1) HK76195A (en)
HU (1) HU201882B (en)
IE (1) IE64348B1 (en)
IL (1) IL89695A0 (en)
NO (1) NO178136C (en)
PH (1) PH25791A (en)
PT (1) PT90153B (en)
RU (1) RU1836083C (en)
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PT90153A (en) 1989-11-10
FI891163A (en) 1989-10-01
NO178136B (en) 1995-10-23
FR2629344B1 (en) 1994-09-16
IE891006L (en) 1989-09-30
DE68907762T3 (en) 2003-11-20
FI891163A0 (en) 1989-03-10
FR2629344A1 (en) 1989-10-06
NO891052L (en) 1989-10-02
ATE91888T1 (en) 1993-08-15
EP0335560A2 (en) 1989-10-04
EP0335560A3 (en) 1990-12-27
PH25791A (en) 1991-11-05
DK156289A (en) 1989-10-01
ZA892131B (en) 1989-11-29
ES2059729T5 (en) 2002-09-16
US5068112A (en) 1991-11-26
CA1339078C (en) 1997-07-29
FI101344B1 (en) 1998-06-15
EP0335560B2 (en) 2002-01-23
HK76195A (en) 1995-05-26
AU3227389A (en) 1989-10-05
KR950007202B1 (en) 1995-07-04
NO891052D0 (en) 1989-03-13
RU1836083C (en) 1993-08-23
NO178136C (en) 1996-01-31
EP0335560B1 (en) 1993-07-28
FI101344B (en) 1998-06-15
BG50712A3 (en) 1992-10-15
AU610711B2 (en) 1991-05-23
DE68907762D1 (en) 1993-09-02
DE68907762T2 (en) 1993-11-11
ES2059729T3 (en) 1994-11-16
IL89695A0 (en) 1989-09-28
IE64348B1 (en) 1995-07-26
DK156289D0 (en) 1989-03-30
HUT50050A (en) 1989-12-28
PT90153B (en) 1994-07-29
HU201882B (en) 1991-01-28

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